Health Canada announces that benzodiazepines and benzodiazepine-like prescription drugs (commonly referred to as “Z-drugs”), which are commonly used to treat sleep and anxiety disorders, certain seizure disorders, and to help relax muscles or relieve muscle pain, can lead to problematic use and substance use disorder. To help mitigate these risks, Health Canada is asking manufacturers to update their safety warnings to include more prominent and consistent messaging for patients and healthcare professionals. The update requested by Health Canada includes language around the risks of:
- problematic use and substance use disorder;
- severe withdrawal symptoms;
- harm when taken with opioids, which may cause deep drowsiness, respiratory depression, coma and death; and
- falls and fractures in specified populations.
The update includes labelling to reflect that problematic use of these medications can result in overdose or death, especially when combined with other medicines. The update also contains information to address the risk of severe and life-threatening withdrawal symptoms that can result from abrupt discontinuation or rapid dose reduction. The Government of Canada is committed to a broad range of activities to help address Canada’s opioid crisis in the areas of prevention, treatment, harm reduction, and enforcement. As part of this commitment, Health Canada is working to strengthen the labelling of benzodiazepines and benzodiazepine-like drugs to better reflect the serious risks when used with opioid drugs.
The list of affected drugs include: clonazepam, diazepam, lorazepam, alprazoalm, chlordiazepoxide, clobazam, flurazepam, oxazepam, nitrazepam, triazolam, temazepam, zopiclone, zolpidem, zaleplon, eszopiclone, bromazepam, clorazepate and midazolam.
Information for healthcare professionals
- Assess a patient’s condition, other medicines taken and the risk of problematic use and substance use disorder prior to prescribing.
- Reserve concomitant prescribing of benzodiazepines and opioids to patients for whom alternative treatment options are not possible.
- Limit dosages and durations to the minimum required.
- Monitor patients for signs and symptoms of respiratory depression and sedation.
- Avoid abrupt discontinuation or rapid dose reduction. Gradually taper to reduce the dose or to discontinue the medication.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../74223a-eng.php
In Hong Kong, there are registered pharmaceutical products containing clonazepam (10 products), diazepam (31 products), lorazepam (9 products), alprazoalm (17 products), chlordiazepoxide (5 products), clobazam (1 product), nitrazepam (4 products), triazolam (1 product), zopiclone (29 products), zolpidem (16 products), bromazepam (4 products) and midazolam (8 products). All products are prescription-only medicines. There is no registered pharmaceutical product containing flurazepam, oxazepam, temazepam, zaleplon, eszopiclone and clorazepate.
So far, the Department of Health (DH) has received adverse drug reaction related to clonazepam (3 cases), diazepam (3 cases, of which one case is related to drug abuse), lorazepam (2 cases, of which one case is related to drug dependence), zopiclone (2 cases), zolpidem (4 cases, of which one case is related to drug dependence) and midazolam (25 cases, of which one case is related to drug abuse). The DH has not received any case of adverse drug reaction related to alprazoalm, chlordiazepoxide, clobazam, nitrazepam, triazolam and bromazepam.
Related news was previously issued by the United States Food and Drug Administration (for benzodiazepines) and Singapore Health Sciences Authority (for zolpidem and zopiclone), and was posted on the Drug Office website on 16 May 2018, 19 Nov 2018 and 24 Sep 2020.
The risk of abuse, tolerance, dependence and withdrawal symptoms, falls and fractures, and drug interactions associated with the use of benzodiazepines and related drugs are documented in overseas reputable drug references such as the “AHFS Drug Information” and “Martindale: The Complete Drug Reference”. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Saturday, Oct 31, 2020
Issued at HKT 13:00
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